Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy

NCT05176119 | Completed Phase 4

• 1 other identifier: MS 160/2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of low dose nalbuphine or ketamine in the prevention of emergence agitation after sevoflurane anesthesia in children undergoing tonsillectomy with or without adenoidectomy. This randomized double-blind study was carried out at, Ain shams University Hospitals, from March 2021 to June 2021 on 90 patients after approval of the ethical committee.

Conditions

Pediatric ALL; Pediatric Anesthesia

Keywords

Emergence agitation; Ketamine; Nalbuphine; Sevoflurane.

Outcome Measures

Primary Outcomes (1)

• Emergence Agitation

  5 step Emergence Agitation scale: describing change in mental status of the children during emergence from general anesthesia. The minimum value is 1 and maximum value is 5, and higher scores mean a better outcome. Score 1 Obtunded with no response to stimulation. Score 2 Asleep but responsive to movement or stimulation Score 3 Awake and responsive Score 4 Crying Score 5 Thrashing behaviour that requires restraint

  At Time zero (The time of extubation)

Secondary Outcomes (8)

• Emergence Agitation at post anesthesia care unit(PACU)

  At time of delivery to PACU

• Post-operative pain

  30 minutes

• Midazolam given for emergence agitation

  30 minutes

• Duration in PACU

  45 minutes

• Time to hospital discharge.

  6 hours

Study Arms (3)

Nalbuphine arm

ACTIVE COMPARATOR

0.1 mg /kg nalbuphine was given to 30 patients

Drug: Nalbuphine Injection

Ketamine arm

ACTIVE COMPARATOR

0.25 mg /kg ketamine was given to 30 patients

Drug: Ketamine

Saline arm

PLACEBO COMPARATOR

an equivalent volume of normal saline was given to 30 patients

Drug: Saline

Interventions

Nalbuphine Injection DRUG

At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.

Nalbuphine arm

Ketamine DRUG

At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.

Ketamine arm

Saline DRUG

At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.

Saline arm

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients undergoing tonsillectomy with or without adenoidectomy
• Age 4 - 10 years.
• Sex: Both sexes
• Patients with ASA classificaion I and II.

You may not qualify if:

• Declining to give written informed consent.
• History of allergy to the medications used in the study.
• psychiatric disorder.
• ASA classification III-V.
• Fever ,cough , asthma or upper respiratory tract infection .
• Anticipated difficult airway .
• Hearing defect .
• Neurological disorder.
• Family history of malignant hyperthermia .

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospitals

Cairo, Al Abbassia, 11591, Egypt

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Emergence Delirium

Interventions

Nalbuphine; Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture of Anesthesia, ICU & Pain mangement faculty od medicine

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: January 4, 2022
• Study Start: March 25, 2021
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)